Longevity · Repurposing · Clinical evidence
> 1

Every Blueprint protocol is N=1. Every Reddit thread on rapamycin, NAD, or a SIBO cure is N=1. Every "it worked for me" is N=1. We take longevity from biohacker to legit — out of anecdote and into evidence: rigorous trials, real endpoints, ill patients, public results.

beyond the anecdote
The thesis

A structural gap in the drug system — and the technology to close it.

Substances with no patent moat — curcumin, berberine, rapamycin, low-dose naltrexone, NAC, urolithin A, peptides, food-derived bioactives — can't attract the $300M+ a traditional FDA approval costs, so they stay stuck: sold as supplements with vague claims, or traded as protocols in a gray zone. Nowhere is this worse than in longevity and gut health, where the loudest anecdotes meet the thinnest evidence and a desperate, self-funding audience runs millions of uncontrolled experiments. The trap is trying to monetize the substance — you can't; the value leaks to generic makers and supplement sellers. So we don't. We build the software stack that makes a rigorous repurposing trial radically cheaper and faster, prove it by running our own — starting in the aging gut — and sell the stack and the speed to everyone else. The evidence is the credibility engine; the software is the business. Longevity is the banner; the gut is where we plant the flag first.

N = 1
  • Anecdote & testimonial
  • Reddit, Blueprint, podcast guests
  • "It worked for me"
  • No endpoint, no rigor
>
N > 1
  • Rigorous, powered RCTs
  • Real clinical endpoints
  • Ill patients, published results
  • Regulator-grade evidence
Why now

An 18–30 month window is open. It will close.

Six forces are aligned simultaneously — a configuration that did not exist two years ago and will not persist.

Regulatory window open
FDA Drug Repurposing RFI published May 2026 (Docket FDA-2026-N-4492); comments due June 11.
Federal momentum
Drug repurposing named a federal priority; FDA Modernization Act 3.0 (S.355) passed the Senate Dec 2025; PCAC peptide vote July 2026.
AI compression proven
Insilico: 18 months and $150K to preclinical (was 4–6 years); Exscientia/Recursion $688M merger validates the platform thesis.
Longevity goes mainstream
Consumer aging-biomarker testing at scale; organ-specific aging clocks validated. A large, self-funding population is already measuring itself.
Gut–aging science maturing
Dysbiosis named among the Hallmarks of Aging (2023); gut-barrier and motility decline increasingly tied to age — a testable bridge from aging to GI disease.
Trial infrastructure maturing
DCT market projected $12B+ by 2030; FDA accepts RWE-based synthetic controls.
What we build

A four-layer vertically integrated stack.

Each layer attacks one cost or time bottleneck in repurposing. Integrated on one data model, they are the product we sell.

01
AI Repurposing Discovery Engine
Knowledge graph + LLM + structural biology, ranking candidates by predicted success at specific disease endpoints — tuned for repurposing, starting with geroscience and the gut.
Compresses discovery from 4–6 yr → ~1 yr
02
Patient Matching + Recruitment
EHR + claims mining and opt-in registries for national reach — plus direct-to-participant recruitment from the longevity and gut communities the CRO model can't touch.
Recruitment 10× faster than the CRO model
03
Decentralized Trial Operating System
One product, one data model: eConsent, randomization, eCRF, ePRO, wearables, telehealth, AE reporting, submission generation. Replaces the Medable + Castor + Veeva + Florence stitch-up.
Replaces the CRO middle layer · 60–80% lower cost
04
Evidence + Biomarkers + Synthetic Controls
RWE-driven control arms plus harmonized aging and gut-age biomarker panels — epigenetic clocks, proteomic and functional measures, wearables and CGM.
Reduces required N by 30–50%
The flywheel: every trial improves the AI · every match sharpens recruitment · every outcome grows the synthetic-control library · every result expands the registry — network effects in clinical research. We run our own trials to prove the cost and speed advantage in public, then license the stack to every other sponsor: we sell the rails, not the substance, and never take a margin on a molecule.
The measurement edge. Aging has no single endpoint, so the stack carries a biomarker layer. A validated gut-age panel is both our beachhead instrument and a product the field badly lacks — today's "gut age" tests are exactly the unvalidated landscape we exist to fix.
Approach

Credibility first. We earn the right to the hard problems.

We don't pick candidates by anecdote, and we don't lead with the highest-demand category. We lead with the one that most strengthens the brand — because the brand is the moat. The first portfolio is chosen with our founding CSO.

Functional-GI, validated endpoint / first
lowest exposure
A clean off-patent generic or nutraceutical in a functional-GI indication with a validated patient-reported endpoint — not the contested SIBO breath-test terrain, and not a peptide.
Why this firstLowest legal exposure, a hard publishable endpoint, and it sits directly on the gut-aging thesis. Banks the "these people do real science" reputation before anything contested.
Gut-aging mechanisms / then
community demand
Motility, barrier, and microbiome — including SIBO/IMO once its diagnostic terrain is on firmer footing.
Why nextWhere the biggest community demand sits — entered once the brand carries the rigor to survive the methodology debates.
Peptides & systemic geroprotectors / later
PCAC-gated
The frontier: enormous demand, almost no regulator-grade evidence, and a path that opens with the PCAC ruling.
Why lastHighest demand and highest credibility risk — entered only once the brand is trusted and the regulatory path resolves.
Each pragmatic trial targets the $2–10M range against a traditional $300M+ path — the compression is both the proof and the pitch.
Structure

Two organizations. Both run trials.

The split is why a trial exists and who funds it, not who operates it. Both run on the same stack; neither ever takes a margin on a substance — the line that keeps the evidence credible.

NGTOne Inc · C-Corp PBC
The business: the platform, IP, registry data, and the trials with a business case, on venture equity and SaaS revenue. A public-benefit charter protects mission-aligned decisions.
N > 1 Foundation · 501(c)(3)/(c)(4)
The independent evidence flank: the trials with only a truth case — the nulls, the debunks, the methodology exemplars no sponsor will fund — on tax-deductible philanthropy, with its own governance.
Discipline

We compete on trust. Rigor is the product, not the overhead.

We are deliberately entering the two fields most synonymous with overclaiming — longevity and the microbiome — which makes rigor our entire differentiation. Non-negotiable from day one:

Preregistered before enrollment
Every trial IRB-approved, IND where required, and registered before the first patient.
Publish every result, including negatives
A definitive null is a win — and often a movement-defining one.
Independent DSMB + statistician
The methodology is separated from any individual. No single voice owns a readout.
No commercial stake in any substance
The platform is the business, not the molecule — so there is no incentive to bias a result.
We correct bad science publicly
Including allies'. No disease claims on unapproved interventions, ever.
The cleanest signal in a noisy field
Preregistration and published negatives over breath-test debates and testimonial threads.
Founding team

Three co-equal founders.

The company is built by an operator and led in public by a scientist — deliberately. The founder builds and runs it; the scientific and clinical seats carry the credibility, and they are co-equal co-founders, not hires.

CEO

Builder / operator

Platform, engineering, fundraising, company-building. Scaled a real-time dispatch operation from zero to a dispatch every other second — the same match-route-fulfill pattern that patient recruitment runs on.

Forming CSO

Public & scientific face

An MD-PhD in GI, microbiome, or geroscience who is frustrated by the field's hype. Owns the methodology and picks the beachhead — the rigor-first voice the company is built around.

Forming CMO

Clinical & regulatory

A clinical-and-regulatory operator who has taken protocols through IRB/IND before. Runs the trials and owns the FDA workflow — because the first year is getting one rigorous trial out the door.

The scientific and clinical seats are being formed now. The CSO is the recruit this whole plan turns on.
Where this goes

Beyond the anecdote — and built to last.

Accumulated evidence and organized patient demand move guidelines, coverage, and policy. Ten years out, > 1 is field shorthand for rigorous repurposing evidence — the way "Cochrane review" is shorthand for systematic review. This is what public science should have been doing all along, built as a private, accountable, durable institution.